Health and Human Services Department Docket FDA-2016-N-0002 Final Rule

2017-03595: New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

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Summary

The Food and Drug Administration (FDA) is withdrawing approval of 18 new animal drug applications (NADAs) and 2 abbreviated new animal drug applications (ANADAs). These withdrawals of approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine's initiative for the Judicious Use of Antimicrobials.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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